Merck Millipore and PharmaCell to Develop Optimized Large-Scale Expansion and Harvesting of HepaRG^® Cells Grown from Bioreactors

• Collaboration to evaluate Merck Millipore’s Mobius^® bioreactor platform for expansion of HepaRG^® cells
• Will help accelerate the commercialization of safe and effective stem cell therapies
• Validation protocols and regulatory documentation will be produced

May 21, 2013, Darmstadt, Germany — Merck Millipore, the Life Science division of Merck, and PharmaCell B.V. today announced a collaboration to develop optimized large-scale expansion and harvest of HepaRG^® cells using bioreactor technology. The companies will work together to produce protocols and methods for efficient expansion, harvest and use of HepaRG^® cells in support of the BALANCE project, which is funded by the Seventh Framework Programme of the European Committee and aims to create bioartificial livers.

Large-scale methods to produce cells have typically been manufactured in multi-layer flasks. Bioreactors provide a method that can meet the needs of large-scale production for safe and effective delivery of cell-based therapies. Ultimately the project is expected to deliver scalable expansion and harvesting devices, validation methods and associated protocols for the production of large-scale stem cell therapies.

Large-scale “industrialized” production of cells is necessary to enable their advancement into human clinical trials and to effectively deliver the quantities efficiently and effectively. However, achieving this level of production while meeting rigorous quality standards will depend on further progress in the areas of cell culture and scale-up, characterization, enrichment and purification to deliver a consistent and reproducible supply of cells.

“As more cell-based therapeutics progress towards clinical testing, the consistency, quality and reproducibility of large-scale culture systems become an imperative,” notes Robert Shaw, Commercial Director of Merck Millipore’s Stem Cell Initiative. “The ability to ensure that a population of cells can be reproducibly produced in a manner that can be validated is critical to the success of clinical applications. The technologies developed as part of this collaboration will help enable this and move the field forward.”

“We are excited to work with Merck Millipore to develop the future technologies for large-scale industrial production of human cells. Merck Millipore’s world-class technical expertise in bioreactors combined with PharmaCell’s advanced know-how in culturing human cells positions the team well to create solutions to overcome some significant technical hurdles in the field and lower future cost of goods sold for our clients,” expresses Alexander Vos, Chief Executive Officer, PharmaCell BV.

This collaboration is another step in the development of a platform of scalable, disposable production solutions to help enable manufacturers of cell-based therapies.

PharmaCell provides GMP contract manufacturing services and process development solutions in the area of cell therapy and regenerative medicine. They will be utilizing the Mobius^® bioreactor platform in support of this project.

For more information, please visit www.merckmillipore.com/mobius or www.pharmacell.nl.

About Merck Millipore
Merck Millipore is the Life Science division of Merck KGaA of Germany and offers a broad range of innovative, performance products, services and business relationships that enable our customers’ success in research, development and production of biotech and pharmaceutical drug therapies. Through dedicated collaboration on new scientific and engineering insights, and as one of the top three R&D investors in the Life Science Tools industry, Merck Millipore serves as a strategic partner to customers and helps advance the promise of life science.

Headquartered in Billerica, Massachusetts, the division has around 10,000 employees, operations in 66 countries and 2012 revenues of €2.6 billion Merck Millipore operates as Merck Millipore in the U.S. and Canada.

Note: Merck KGaA or Merck shall mean Merck KGaA, Darmstadt, Germany

About PharmaCell
PharmaCell is a leading European-based CMO active in the area of cell therapy and regenerative medicine. We have experience in supporting Phase I through Phase III clinical trials in cell therapy in terms of manufacturing, QC, storage, in-outgoing logistics and product release through our in-house QPs. We are exclusively focused on providing contract services in the area of human cell therapy. Our services also include process and assay-development to ensure GMP compliance, robustness and scalability of cell therapy manufacturing processes.

PharmaCell operates a state-of-the art cGMP certified facility situated adjacent to the Maastricht University Hospital and within 15 minutes from both the German and Belgian border. Several airports are located close to Maastricht. The facility covers 1400 square meters including clean rooms, grade A, B, C and D. (Classes 100 / 10,000 / 100,000), R&D and QC laboratories including cryopreservation, warehouse and logistics areas.

Information on the BALANCE project can be found at www.fp7balance.eu.